How CathWorks Leaned on Its Partner Medtronic to Succeed
CathWorks, an AI‑driven startup that creates non‑invasive FFR assessments from routine angiograms, survived the pandemic by leaning on Medtronic’s early minority investment and strategic guidance. After automating its 3‑D coronary modeling to cut analysis time from 22 minutes to two, the company secured FDA, EU and Japan clearances and completed five global validation studies. Medtronic announced a deal to acquire CathWorks for up to $585 million, aiming to embed the technology in its cath‑lab portfolio. The acquisition comes as CathWorks prepares to present a 1,900‑patient randomized trial at the ACC meeting.
This Startup Developed a First-of-Its-Kind Brain Function Assessment Device
QuantalX secured FDA de novo clearance for Delphi‑MD, a first‑of‑its‑kind device that fuses transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to deliver real‑time brain network function assessments. The system leverages proprietary algorithms and an age‑correlated normative database to generate actionable...
Lubrizol Launches Tolerathane TPU for Implantable Medical Devices
Lubrizol has launched Tolerathane™ TPU, a medical‑grade thermoplastic polyurethane designed for implantable devices. The material offers superior resistance to oxidative and hydrolytic degradation while maintaining exceptional softness and mechanical resilience. It integrates with standard thermal processing, enabling thinner‑wall, miniaturized designs...
AdvaMed Names New EVP of Technology and Regulatory Affairs
AdvaMed announced Melissa Torres as its new executive vice president of technology and regulatory affairs, succeeding long‑time leader Janet Trunzo. Torres arrives with more than two decades of FDA leadership, most recently as associate director for international affairs at CDRH....
Respiratory Care, Stroke Care, and Women’s Health: Philips CMO on the Exciting Possibilities in Digital Health
Philips Chief Medical Officer Dr. Carla Goulart Peron outlined the company’s push into digital health, emphasizing expanded CPAP and respiratory solutions integrated with consumer wearables. She highlighted AI’s role in early detection, especially for stroke and women’s heart disease, while...
FDA’s New Guidance on Consumer Wearables Makes the Medtech Market More Complex
The FDA’s new guidance clarifies, rather than rewrites, the line between general‑wellness wearables and regulated medical devices, emphasizing intended use as the decisive factor. By allowing sensor‑rich products to remain unregulated if they avoid medical claims, the agency reduces regulatory...